GYNECOLOGICAL DEVICE
20210338284 · 2021-11-04
Inventors
- Dany WYSSEN (Biel/Bienne, CH)
- Julien FINCI (Basel, CH)
- Frédéric FLAHAUT (Neuchâtel, CH)
- Anne POLIKEIT (Biel/Bienn, CH)
- Marion AEBY (Villars-sur-Glâne, CH)
- Luc BERGERON (Boussens, CH)
- Laurent SOLDINI (Lausanne, CH)
Cpc classification
A61B17/4241
HUMAN NECESSITIES
International classification
Abstract
The present invention relates to a gynecological device (1) comprising a body part (2) having a vacuum chamber (3), a rod unit (4) with a distal end, a proximal end, and a channel (41) extending between the distal end and the proximal end, a cervix head (5) arranged at the distal end of the rod unit (4), and a sealing mechanism (6) configured to switch between an ambient state and a vacuum state. The rod unit (4) extends to the vacuum chamber (3) of the body part (2) such that the proximal end of the rod unit (4) is located in the vacuum chamber (3) of the body part (2). The cervix head (5) is configured to engage a section of a cervix from a vaginal side. When in the ambient state of the sealing mechanism (6), the vacuum chamber (3) of the body part (2) is sealed and the channel (41) of the rod unit (4) is open to an exterior (7) of the gynecological device (1). In the vacuum state of the sealing mechanism (6), the channel (41) of the rod unit (4) is open to the vacuum chamber (3) of the body part (2) and sealed to the exterior (7) of the gynecological device (1).
Claims
1.-27. (canceled)
28. A gynecological device comprising: a body part having a vacuum chamber; a rod unit with a distal end, a proximal end, and a channel extending between the distal end and the proximal end; a cervix head arranged at the distal end of the rod unit; and a sealing mechanism configured to switch between an ambient state and a vacuum state, wherein the rod unit extends to the vacuum chamber of the body part such that the proximal end of the rod unit is located in the vacuum chamber of the body part, the cervix head is configured to engage a section of a cervix from a vaginal side, in the ambient state of the sealing mechanism, the vacuum chamber of the body part is sealed and the channel of the rod unit is open to an exterior of the gynecological device, and in the vacuum state of the sealing mechanism, the channel of the rod unit is open to the vacuum chamber of the body part and sealed to the exterior of the gynecological device.
29. The gynecological device of claim 28, wherein the sealing mechanism comprises a sleeve element arranged in the vacuum chamber of the body part, and the sleeve element comprises an activation part extending to an exterior of the body part, wherein the rod unit extends through the sleeve element, and wherein the sleeve element is axially movable relative to the vacuum chamber and relative to the rod unit along an axis of the rod unit and/or of the gynecological device.
30. The gynecological device of claim 29, wherein the sleeve element of the sealing mechanism has an internal seal member that is configured to seal the sleeve element and the rod unit towards each other.
31. The gynecological device of claim 30, wherein the sleeve element of the sealing mechanism has an external seal member sealing the sleeve element and the vacuum chamber of the body part towards each other.
32. The gynecological device of claim 31, wherein a first friction force between the internal seal member of the sleeve element of the sealing mechanism and the rod unit is smaller than a second friction force between the external seal member of the sleeve element of the sealing mechanism and the vacuum chamber of the body part.
33. The gynecological device of claim 31, wherein the internal seal member and the external seal member of the sleeve element of the sealing mechanism are axially offset from each other along the axis, wherein the internal seal member of the sleeve element of the sealing mechanism is closer to the distal end of the rod unit than the external seal member of the sleeve element of the sealing mechanism.
34. The gynecological device of claim 30, wherein in the ambient state of the sealing mechanism, the sleeve element is axially moved in a first position in which the internal seal element seals the channel of the rod unit and the vacuum chamber of the body part towards each other, and the external seal element seals the vacuum chamber of the body part towards the exterior of the gynecological device.
35. The gynecological device of claim 30, wherein in the vacuum state of the sealing mechanism, the sleeve element is axially moved in a second position in which the internal seal element seals the channel of the rod unit towards the exterior of the gynecological device, and the external seal element seals the vacuum chamber of the body part towards the exterior of the gynecological device.
36. The gynecological device of claim 29, wherein the rod unit has a projection configured to abut the sleeve element when the rod unit is moved in a distal direction along its axis through the sleeve element, wherein the projection of the rod unit is positioned such that the rod unit is movable to a predefined extent along its axis through the sleeve element.
37. The gynecological device of claim 28, wherein the rod unit has a lateral through hole open to the channel of the rod unit.
38. The gynecological device of claim 28, comprising a cap closing the channel of the rod unit at the proximal end of the rod unit.
39. The gynecological device of claim 38, wherein the sealing mechanism comprises a sleeve element arranged in the vacuum chamber of the body part, wherein the rod unit extends through the sleeve element, wherein the sleeve element is axially movable relative to the vacuum chamber of the body part and relative to the rod unit along an axis of the rod unit and/or of the gynecological device, and wherein the cap is dimensioned not to fit into the sleeve element of the sealing mechanism.
40. The gynecological device of claim 28, further comprising a locking mechanism configured to switch between a released state in which the rod unit is axially movable relative to the vacuum chamber of the body part and a locked state in which movement of the rod unit into the ambient state is prevented, wherein, in the released state of the locking mechanism, the rod unit is axially movable relative to the vacuum chamber of the body part, such that a vacuum is generated inside the vacuum chamber when the rod unit is distally moved relative to the vacuum chamber.
41. The gynecological device of claim 40, wherein the locking mechanism is configured such that pivoting the rod unit about its longitudinal axis in one direction switches the locking mechanism into the locked state and pivoting the rod unit about its axis in another opposite direction switches the locking mechanism into the released state.
42. The gynecological device of claim 40, wherein the rod unit has a lateral through hole open to the channel of the rod unit and the gynecological device is configured to open the through hole to the vacuum chamber of the body part when being in the locked state.
43. The gynecological device of claim 42, wherein the through hole is open to the vacuum chamber of the body part when being in the released state, and/or the gynecological device is configured to open the through hole by applying a push force to the cervix head.
44. The gynecological device of claim 28, the gynecological device being configured to be arranged in a pre-operation state in which the rod unit is moved to a maximum extent in a proximal direction into the vacuum chamber of the body part, wherein the vacuum chamber of the body part has a main section and a proximal section, the main section having a first diameter and the proximal section having a second diameter that is bigger than the first diameter.
45. The gynecological device of claim 44, wherein the sleeve element of the sealing mechanism has an internal seal member sealing the sleeve element and the rod unit towards each other, and an external seal member sealing the sleeve element and the vacuum chamber of the body part towards each other, and wherein the external seal member is compressed when being positioned in the main section of the vacuum chamber of the body part, and the external seal member is non-compressed when being positioned in the proximal section of the vacuum chamber of the body part.
46. The gynecological device of claim 44, wherein in an inclined transition section between the proximal section of the vacuum chamber of the body part and the main section of the vacuum chamber of the body part a diameter decreases from the second diameter to the first diameter.
47. The gynecological device of claim 28, wherein a friction reduction substance is provided between an internal seal member of the sleeve element of the sealing mechanism and the rod unit, wherein the friction reduction substance comprises a silicone oil.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0048] The gynecological device according to the invention is described in more detail herein below by way of an exemplary embodiment and with reference to the attached drawings, in which:
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DESCRIPTION OF EMBODIMENTS
[0062] In the following description certain terms are used for reasons of convenience and are not intended to limit the invention. The terms “right”, “left”, “up”, “down”, “under” and “above” refer to directions in the figures. The terminology comprises the explicitly mentioned terms as well as their derivations and terms with a similar meaning. Also, spatially relative terms, such as “beneath”, “below”, “lower”, “above”, “upper”, “proximal”, “distal”, and the like, may be used to describe one element's or feature's relationship to another element or feature as illustrated in the figures. These spatially relative terms are intended to encompass different positions and orientations of the devices in use or operation in addition to the position and orientation shown in the figures. For example, if a device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be “above” or “over” the other elements or features. Thus, the exemplary term “below” can encompass both positions and orientations of above and below. The devices may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein interpreted accordingly. Likewise, descriptions of movement along and around various axes include various special device positions and orientations.
[0063] To avoid repetition in the figures and the descriptions of the various aspects and illustrative embodiments, it should be understood that many features are common to many aspects and embodiments. Omission of an aspect from a description or figure does not imply that the aspect is missing from embodiments that incorporate that aspect. Instead, the aspect may have been omitted for clarity and to avoid prolix description. In this context, the following applies to the rest of this description: If, in order to clarify the drawings, a figure contains reference signs which are not explained in the directly associated part of the description, then it is referred to previous or following description sections. Further, for reason of lucidity, if in a drawing not all features of a part are provided with reference signs it is referred to other drawings showing the same part. Like numbers in two or more figures represent the same or similar elements.
[0064] With reference to
[0065] A cervix head 5, configured to engage a section of a cervix from a vaginal side and to conform to its anatomy, is arranged at the distal end of the rod unit 4, in a way that the cervix head 5 is in fluid communication with the channel 41. The rod unit 4 therefore guarantees that vacuum created in the vacuum chamber 3 inside the body part 2 can be transferred to the cervix head 5 contacting the cervix.
[0066] The body part 2 of the gynecological device 1 also comprises a back cap 22, closing the substantially tubular body part 2 and proximally guaranteeing air tightness at a back end of the body part 2. The back cap 22 is also configured to be easily grippable by an operator or practitioner when using the device 1. For this purpose, for instance, the back cap 22 can have a bigger diameter than the rest of the body part 2. Additionally or alternatively, the back cap 22 can be provided with a wing-like structure or an extended finger flange structure to facilitate traction, if needed.
[0067] The rod unit 4 can be extracted and re-positioned inside the body part 2 by way of a translation movement. The body part 2 further comprises a front cap 21 distally partially closing a front end of the device 1. The front cap 21 which cooperates with the rod unit 4 to guide the translation movement of the rod unit 4 as well as to eventually lock the position of the rod unit 4 once extended.
[0068] A sealing mechanism 6 is configured to switch between an ambient state and a vacuum state. As exemplified in
[0069] In order to alternatively put the channel 41 of the rod unit 4 in connection with the exterior 7 or with the vacuum chamber 3, the rod unit 4 is provided with a lateral through hole 42 open to the channel 41. Like this, respectively the pressure in the channel 41 equals that of the exterior 7 when in the ambient state or that of the vacuum chamber when in the vacuum state.
[0070] A cap 12, which can take the form of a piston head, closes the channel 41 of the rod unit 4 at the proximal end of the rod unit 4.
[0071] The sealing mechanism 6 comprises a sleeve element 8 arranged in the vacuum chamber 3 of the body part 2. The rod unit 4 extends through the sleeve element 8. The sleeve element 8 is axially movable relative to the vacuum chamber 3 and relative to the rod unit 4 along the axis A-A of the rod unit 4. The axis A-A in this case substantially coincides with the axis of the complete gynecological device 1.
[0072] The cap 12 is dimensioned not to fit into the sleeve element 8 of the sealing mechanism 6, preventing the decoupling of rod unit 4 and sleeve element 8.
[0073] Thus, as shown in
[0074] In
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[0076] Moreover, the sleeve element 8 of the sealing mechanism 6 has an external seal member 10 sealing the sleeve element 8 and the vacuum chamber 3 of the body part 2, or generally the internal walls of the body part 2, towards each other.
[0077] The internal seal member 9 and the external seal member 10 of the sleeve element 8 of the sealing mechanism 6 are axially offset from each other along the axis (A-A). Namely, the internal seal member 9 of the sleeve element 8 of the sealing mechanism 6 is closer to the distal end of the rod unit 4 than the external seal member 10 of the sleeve element 8 of the sealing mechanism 6. This disposition of the seal members 9, 10, in combination with the displacement of the rod unit 4 and a consequent positioning of the lateral through hole 42, as well as with the calibrated axial movement of the sleeve element 8, allows to precisely achieve the abovementioned ambient and vacuum states, as portrayed in
[0078] In
[0079] In
[0080] In order for the sleeve element 8 to reach the second position of
[0081] By sliding back the sleeve element 8, at point IV of
[0082] A first friction force between the internal seal member 9 of the sleeve element 8 of the sealing mechanism 6 and the rod unit 4 is smaller than a second friction force between the external seal member 10 of the sleeve element 8 of the sealing mechanism 6 and the vacuum chamber 3.
[0083] The above friction force distribution allows to bring the device 1 from the initial position of the device 1 just out of packaging portrayed at point I of
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[0085] As it can be appreciated from the fourth of the section views of
[0086] As a consequence of the above design, the external seal member 10 comes to be compressed when being positioned in the main section 31 of the vacuum chamber 3 of the body part 2, and the external seal member 10 is instead non-compressed when being positioned in the proximal section 32 of the vacuum chamber 3 of the body part 2. Stress is therefore avoided on the external seal member 10 when unneeded, that is during shelf life, ensuring that the seal will on the other hand perform appropriately when the device 1 is in use.
[0087] Moreover, in order to secure a friction force on the external seal member 10 larger than on the internal seal member 9 for the purpose of initial vacuum, chamber 3 formation and separation from the residual chamber 33, not only the geometry of the seal member 10 can be purposely chosen, but also an inclined transition section can be created between the proximal section 32 of the vacuum chamber 3 of the body part 2 and the main section 31 of the vacuum chamber 3 of the body part 2. Thus, a diameter of the internal walls of the body part 2 decreases from the second diameter D to the first diameter d. Several geometries and angles are possible for the above inclined plan of the inclined transition section, calibrated to different resulting friction forces. Alternatively, also a radius on the inner diameter edge of the main section 31 can be created, to create a friction force variation.
[0088] In order to slide forward, in a distal direction, the sleeve element 8 from the first position at point II of
[0089] In
[0090] The projection 43 of the rod unit 4 is positioned such that the rod unit 4 is movable to a predefined extent along its axis A-A through the sleeve element 8.
[0091] In
[0092] The locking mechanism is created by the cooperation of protrusions 44 on the rod unit 4 which, while free to slide within the front cap 21 when in the released state, engage instead in corresponding female recesses of the front cap 21 when in the locked state, preventing the rod unit 4 from translating either in a distal or in a proximal direction. Thus, in the locked state, the rod unit 4 stays fixed, while the vacuum is activated, and does not translate back to its initial position as it would instead tend to do, owing to the force exerted by the vacuum which is established in the vacuum chamber 3.
[0093] The locking mechanism created by the protrusions 44 and the corresponding female recesses in the front cap 21 is configured such that pivoting the rod unit 4 about its longitudinal axis A-A in one direction switches the locking mechanism into the locked state, whereas pivoting the rod unit 4 about its axis in another opposite direction switches the locking mechanism into the released state.
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[0102] A cervix head 50, designed to engage a section of a cervix from a vaginal side and to conform to its anatomy, is arranged at the distal end of the rod unit 40 to be in fluid communication with the channel 410. The rod unit is further provided with lateral through holes 420 radially opening the channel 410 near the cap 120.
[0103] The body part 20 of the gynecological device 1′ comprises a releasable elastic back cap 60 tightly closing a back end of the body part 20. The body part 20 further comprises a front cap distally closing a front end. The front cap cooperates with the rod unit 40 to guide a translation movement of the rod unit 40. A sealing mechanism is configured to switch between an ambient state and a vacuum state as described in the following.
[0104] Depicted at I in
[0105] As depicted at II in
[0106] As depicted at III in
[0107] As depicted at IV of
[0108] This description and the accompanying drawings that illustrate aspects and embodiments of the present invention should not be taken as limiting the claims defining the protected invention. In other words, while the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive. Various mechanical, compositional, structural, electrical, and operational changes may be made without departing from the spirit and scope of this description and the claims. In some instances, well-known circuits, structures and techniques have not been shown in detail in order not to obscure the invention. Thus, it will be understood that changes and modifications may be made by those of ordinary skill within the scope and spirit of the following claims. In particular, the present invention covers further embodiments with any combination of features from different embodiments described above and below.
[0109] The disclosure also covers all further features shown in the Figs. individually although they may not have been described in the afore or following description. Also, single alternatives of the embodiments described in the figures and the description and single alternatives of features thereof can be disclaimed from the subject matter of the invention or from disclosed subject matter. The disclosure comprises subject matter consisting of the features defined in the claims or the exemplary embodiments as well as subject matter comprising said features.
[0110] Furthermore, in the claims the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. A single unit or step may fulfil the functions of several features recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. The terms “essentially”, “about”, “approximately” and the like in connection with an attribute or a value particularly also define exactly the attribute or exactly the value, respectively. The term “about” in the context of a given numerate value or range refers to a value or range that is, e.g., within 20%, within 10%, within 5%, or within 2% of the given value or range. Components described as coupled or connected may be electrically or mechanically directly coupled, or they may be indirectly coupled via one or more intermediate components. Any reference signs in the claims should not be construed as limiting the scope.